MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Complaint, Ill-Defined (2331); Injury (2348); Numbness (2415); Ambulation Difficulties (2544); Disc Impingement (2655)
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Event Date 08/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare provider (hcp) via a clinical study regarding a patient with an implantable neurostimulator (ins).It was reported that the patient was experiencing back pain exacerbation.The hcp stated that the patient started having pain over their midline lower back wounds and on the right lateral back incision site.In addition, the patient had numbness, difficulty walking, and pain in their bilateral lower extremities.Interventions included hospitalization and medications administered.Diagnostic testing revealed multiple disc protrusions and enhancement of fluid around the ins.The etiology of the event was noted as not related to the device and possibly related to the therapy.The outcome of the event was noted as recovering/resolving.No further complications were reported or anticipated.Indication for use is spinal pain.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a healthcare provider (hcp) via manufacturer representative.It was reported that it was possible that the patient¿s multiple disc protrusions were related to the device or therapy.The manufacturer representative stated that the issues of back pain/lower back wounds, numbness, difficulty walking, disc protrusions, and fluid around the implant site have all been resolved.No further complications were reported or anticipated.
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Search Alerts/Recalls
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